BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART

    MDR report key: 803852 · Received June 14, 2006

    Report

    Report Number
    9610483-2006-00107
    Event Type
    Other
    Date Received
    June 14, 2006
    Date of Event
    August 3, 2000
    Report Date
    August 17, 2000
    Manufacturer
    LAERDAL MEDICAL A.S.
    Product Code
    LDD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEFIBRILLATOR WAS TESTED USING A KNOWN GOOD POWER SUPPLY, AND PROPER OPERATION WAS VERIFIED. BOTH OF THE RETURNED EXPIRED BATTERIES WERE TESTED, ONE LAERDAL BATTERY LOT 961129 AND ONE NON-LAERDAL BATTERY LOT 940412, AND BOTH CAUSED THE UNIT TO SHUT DOWN DURING THE CHARGE CYCLE PROMPTING "REPLACE BATTERY, BATTERY LOW." BOTH FAILED THE PERIODIC BATTERY CAPACITY TEST DEFINED IN THE HS3000 OPERATING INSTRUCTIONS. THE MESSAGE "REPLACE BATTERY, BATTERY LOW" PROMPTS WHEN THE BATTERY LACKS THE CAPACITY TO PERFORM AS REQUIRED AND THE DEFIBRILLATOR SHUTS DOWN. THE INCIDENT REPORT PRINTED FROM THE RETURN MCM DOCUMENTS, THE UNIT WAS POWERED ON 3 TIMES DURING THE INCIDENT IN 2000; EACH TIME THE UNIT ANALYZED THE RHYTHM AS TREATABLE, BEGAN CHARGING, AND SHUT DOWN DURING THE CHARGE CYCLE PROMPTING "REPLACE BATTERY, BATTERY LOW. SENT A LETTER EXPLAINING THE LIFE AND MAINTENANCE OF THE LAERDAL BATTERY PER THE HS3000 DFU, POINTING OUT THE IMPORTANCE OF PERIODIC BATTERY CAPACITY TESTS AND REPLACEMENT AFTER TWO YEARS. THIS REPORT IS THE RESULT OF A RETROSPECTIVE COMPLAINT REVIEW BY LMC. IT IS TIMELY FILED UNDER LMC'S REVISED MDR PROCEDURE AND ITS WRITTEN COMMITMENT TO THE AGENCY, EACH OF WHICH HAS RESULTED FROM LAERDAL'S RECEIVING INFORMATION RELATING THE AGENCY'S CURRENT THINKING WITH RESPECT TO MDR REGULATION INTERPRETATION AND ENFORCEMENT POLICY.

    Description of Event or Problem · 1

    DURING AN INCIDENT IN 2000 INVOLVING A MALE PATIENT IN CARDIAC ARREST, THIS DEFIBRILLATOR BEGAN TO CHARGE AND SHUT DOWN READING "CHANGE BATTERY". THE BATTERY WAS CHANGED AND AGAIN THE UNIT BEGAN TO CHARGE, AND THEN SHUT DOWN READING "CHANGE BATTERY." CPR WAS CONTINUED THROUGHOUT. THIS INCIDENT TOOK PLACE AT A MEDICAL FACILITY, BUT NO SAED WAS AVAILABLE ON PREMISE. THE PATIENT WAS PRONOUNCED AT THE SCENE. AT THE STAR OF TOUR, THIS DEFIBRILLATOR WAS CHECKED AND READ "SELFTEST OK". AFTER THE INCIDENT, THE DEFIBRILLATOR WAS CHECKED AGAIN, AND IT READ "SELFTEST OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART SAED LDD LAERDAL MEDICAL A.S. HS3000 9704

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other